Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Guidance for Industry, Revision 1; Availability, 52062-52063 [2024-13674]
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Federal Register / Vol. 89, No. 120 / Friday, June 21, 2024 / Notices
submissions of investigational new drug
applications have been approved under
OMB control number 0910–0014. The
collections of information in 21 CFR
part 314 for the submissions of new
drug applications have been approved
under OMB control number 0910–0001.
The collections of information in 21
CFR part 601 for the submissions of
biologics license application and
supplemental applications have been
approved under OMB control number
0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: June 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13429 Filed 6–20–24; 8:45 am]
and EQ 24 mg base; ANDA 206672,
Entecavir Tablets, 0.5 mg and 1 mg; and
ANDA 209550, Tenofovir Disoproxil
Fumarate Tablets, 300 mg. Before FDA
withdrew the approval of these ANDAs,
Target Health LLC, informed FDA that
it did not want the approval of the
ANDAs withdrawn. Because Target
Health LLC, timely requested that
approvals of ANDAs 076280, 077021,
077310, 077517, 206672, and 209550
not be withdrawn, the approvals are still
in effect. This notice corrects that error.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 301–
796–3471, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Friday, March 29,
2024 (89 FR 22155), appearing on page
22155 in FR Doc. 2024–06730, the
following correction is made:
On page 22155, in the table, the
entries for ANDAs 076280, 077021,
077310, 077517, 206672, and 209550 are
removed.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
[FR Doc. 2024–13658 Filed 6–20–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4164–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2024–N–0020]
SpecGX, LLC, et al.; Withdrawal of
Approval of 30 Abbreviated New Drug
Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on March 29, 2024. The
document announced the withdrawal of
approval of 30 abbreviated new drug
applications (ANDAs) from multiple
applicants, withdrawn as of April 29,
2024. The document indicated that FDA
was withdrawing approval of the
following ANDAs after receiving
withdrawal requests from Target Health
LLC, U.S. Agent for CASI
Pharmaceuticals, Inc., 450 Commerce
Blvd., Carlstadt, NJ 07072: ANDA
076280, Tizanidine Hydrochloride (HCl)
Tablets, Equivalent to (EQ) 2 milligrams
(mg) base and EQ 4 mg base; ANDA
077021, Cilostazol Tablets, 100 mg;
ANDA 077310, Cilostazol Tablets, 50
mg; ANDA 077517, Ondansetron HCl
Tablets, EQ 4 mg base, EQ 8 mg base,
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:46 Jun 20, 2024
Jkt 262001
Food and Drug Administration
[Docket No. FDA–2013–D–0710]
Circumstances That Constitute
Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection;
Guidance for Industry, Revision 1;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled, ‘‘Circumstances That
Constitute Delaying, Denying, Limiting,
or Refusing a Drug or Device
Inspection.’’ The FDA Reauthorization
Act of 2017 (FDARA) amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) so that, as is the case with
a drug, a device is deemed to be
adulterated if the owner, operator, or
agent of the factory, warehouse, or
establishment at which the device is
manufactured, processed, packed, or
held delays, denies, or limits an FDA
SUMMARY:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
inspection. This final guidance
describes, for both drugs and now
devices, the types of behaviors (actions,
inactions, and circumstances) that FDA
considers to constitute delaying,
denying, or limiting inspection, or
refusing to permit entry or inspection.
This guidance finalizes the draft
guidance of the same title issued on
December 16, 2022, and supersedes the
October 2014 final guidance entitled,
‘‘Circumstances That Constitute
Delaying, Limiting, or Refusing a Drug
Inspection.’’
DATES: The announcement of the
guidance is published in the Federal
Register on June 21, 2024.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
E:\FR\FM\21JNN1.SGM
21JNN1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 120 / Friday, June 21, 2024 / Notices
2013–D–0710 for ‘‘Circumstances That
Constitute Delaying, Denying, Limiting,
or Refusing a Drug or Device
Inspection.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for a single
hard copy of the guidance entitled
‘‘Circumstances That Constitute
Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection’’
to the Office of Policy, Compliance and
Enforcement, Office of Regulatory
Affairs, Food and Drug Administration,
VerDate Sep<11>2014
17:46 Jun 20, 2024
Jkt 262001
12420 Parklawn Drive, Element
Building, Rockville, MD 20857. Send
one self-addressed adhesive label to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Lola
Burford, Office of Regulatory Affairs,
Division of Operational Policy, Food
and Drug Administration, 12420
Parklawn Drive, Element Building,
Rockville, MD 20857, Lola.Burford@
fda.hhs.gov, 240–402–5865.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the Food and Drug
Administration Safety and Innovation
Act (FDASIA) (Pub. L. 112–144) added
section 501(j) to the FD&C Act (21
U.S.C. 351(j)) to deem adulterated a
drug that ‘‘has been manufactured,
processed, packed, or held in any
factory, warehouse, or establishment
and the owner, operator, or agent of
such factory, warehouse, or
establishment delays, denies, or limits
an inspection, or refuses to permit entry
or inspection.’’ Section 707(b) of
FDASIA required the Food and Drug
Administration to issue guidance that
defined the circumstances that would
constitute delaying, denying, or limiting
inspection, or refusing to permit entry
or inspection, for purposes of section
501(j). In the Federal Register of
October 22, 2014 (79 FR 63130), FDA
announced the availability of a guidance
for industry entitled, ‘‘Circumstances
That Constitute Delaying, Denying,
Limiting, or Refusing a Drug Inspection’’
(hereinafter, 2014 guidance).
Subsequently, on August 18, 2017,
FDARA (Pub. L. 115–52) was signed
into law. Section 702 of FDARA
amended the scope of section 501(j) of
the FD&C Act to provide that, as the
case with drugs, devices are deemed to
be adulterated if an FDA inspection is
delayed, denied, limited, or refused by
the owner, operator, or agent of the
establishment at which the device is
manufactured, processed, packed, or
held. This final guidance supersedes the
2014 final guidance to incorporate
devices and to explain the
circumstances that FDA would consider
to constitute delaying, denying, or
limiting inspection, or refusing to
permit entry or inspection, resulting in
a drug or device manufactured in the
facility being deemed adulterated.
This final guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
FDA considered the comments received
on the draft guidance and did not make
substantial changes from the draft to the
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
52063
final guidance. This final guidance
represents the current thinking of FDA
on ‘‘Circumstances That Constitute
Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/search-general-and-crosscutting-topics-guidance-documents or
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Circumstances That Constitute
Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection’’
may send an email request to
ORAPolicyStaffs@fda.hhs.gov to receive
an electronic copy of the document.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13674 Filed 6–20–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0783]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Establishment
Registration and Product Listing for
Manufacturers of Human Blood and
Blood Products and Licensed Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
SUMMARY:
E:\FR\FM\21JNN1.SGM
21JNN1
Agencies
[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52062-52063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13674]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0710]
Circumstances That Constitute Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection; Guidance for Industry, Revision
1; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled, ``Circumstances That
Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device
Inspection.'' The FDA Reauthorization Act of 2017 (FDARA) amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act) so that, as is the case
with a drug, a device is deemed to be adulterated if the owner,
operator, or agent of the factory, warehouse, or establishment at which
the device is manufactured, processed, packed, or held delays, denies,
or limits an FDA inspection. This final guidance describes, for both
drugs and now devices, the types of behaviors (actions, inactions, and
circumstances) that FDA considers to constitute delaying, denying, or
limiting inspection, or refusing to permit entry or inspection. This
guidance finalizes the draft guidance of the same title issued on
December 16, 2022, and supersedes the October 2014 final guidance
entitled, ``Circumstances That Constitute Delaying, Limiting, or
Refusing a Drug Inspection.''
DATES: The announcement of the guidance is published in the Federal
Register on June 21, 2024.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-
[[Page 52063]]
2013-D-0710 for ``Circumstances That Constitute Delaying, Denying,
Limiting, or Refusing a Drug or Device Inspection.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for a single hard copy of the guidance
entitled ``Circumstances That Constitute Delaying, Denying, Limiting,
or Refusing a Drug or Device Inspection'' to the Office of Policy,
Compliance and Enforcement, Office of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Drive, Element Building, Rockville, MD
20857. Send one self-addressed adhesive label to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Lola Burford, Office of Regulatory
Affairs, Division of Operational Policy, Food and Drug Administration,
12420 Parklawn Drive, Element Building, Rockville, MD 20857,
[email protected], 240-402-5865. SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144) added section 501(j) to the
FD&C Act (21 U.S.C. 351(j)) to deem adulterated a drug that ``has been
manufactured, processed, packed, or held in any factory, warehouse, or
establishment and the owner, operator, or agent of such factory,
warehouse, or establishment delays, denies, or limits an inspection, or
refuses to permit entry or inspection.'' Section 707(b) of FDASIA
required the Food and Drug Administration to issue guidance that
defined the circumstances that would constitute delaying, denying, or
limiting inspection, or refusing to permit entry or inspection, for
purposes of section 501(j). In the Federal Register of October 22, 2014
(79 FR 63130), FDA announced the availability of a guidance for
industry entitled, ``Circumstances That Constitute Delaying, Denying,
Limiting, or Refusing a Drug Inspection'' (hereinafter, 2014 guidance).
Subsequently, on August 18, 2017, FDARA (Pub. L. 115-52) was signed
into law. Section 702 of FDARA amended the scope of section 501(j) of
the FD&C Act to provide that, as the case with drugs, devices are
deemed to be adulterated if an FDA inspection is delayed, denied,
limited, or refused by the owner, operator, or agent of the
establishment at which the device is manufactured, processed, packed,
or held. This final guidance supersedes the 2014 final guidance to
incorporate devices and to explain the circumstances that FDA would
consider to constitute delaying, denying, or limiting inspection, or
refusing to permit entry or inspection, resulting in a drug or device
manufactured in the facility being deemed adulterated.
This final guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). FDA considered the
comments received on the draft guidance and did not make substantial
changes from the draft to the final guidance. This final guidance
represents the current thinking of FDA on ``Circumstances That
Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device
Inspection'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents or https://www.regulations.gov. Persons unable to download an
electronic copy of ``Circumstances That Constitute Delaying, Denying,
Limiting, or Refusing a Drug or Device Inspection'' may send an email
request to [email protected] to receive an electronic copy of
the document.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13674 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P